Back to resultsMetoprolol Treatment for Cytokine Release Syndrome in Patients Treated With Chimeric Antigen Receptor T Cells
Primary Purpose
Solid Tumor, Hematological Malignancy
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Metoprolol
metoprolol, infliximab, etanercept, tocilizumab and/or other agents
Sponsored by
About this trial
This is an interventional treatment trial for Solid Tumor focused on measuring Metoprolol, cytokine release syndrome, chimeric antigen receptor T cells
Eligibility Criteria
Inclusion Criteria:
- Patients with lymphoma, leukemia or other malignant diseases who were enrolled for CAR T cell therapy.
Exclusion Criteria:
Patients with contraindications indicated in metoprolol instruction, including:
- Significant bradycardia (heart rate < 45/min)
- Cardiogenic shock
- Severe or acute heart failure
- Poor peripheral circulation perfusion
- Grade II or III atrioventricular block
- Sick sinus syndrome
- Severe peripheral vascular disease
Sites / Locations
- Biotherapeutic Department of Chinese PLA General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Conditional therapy mode group
Prophylactic therapy mode group
Arm Description
Metoprolol (12.5-25 mg per dose, every 12 hours) was initially given from the day of CRS diagnosis confirmation post CAR T cell infusions till CRS remission in patients without bulky tumor burden. For all metoprolol-treated patients, the use of antibodies (infliximab, etanercept and tocilizumab) and/or other agents were not completely limited under the consideration of clinical requirement for sufficient control of continuously progressed CRS.
Metoprolol (12.5-25 mg per dose, every 12 hours) was given starting from the day before CAR T infusion till CRS remission in patients with bulky disease. For all metoprolol-treated patients, the use of antibodies (infliximab, etanercept and tocilizumab) and/or other agents were not completely limited under the consideration of clinical requirement for sufficient control of continuously progressed CRS.
Outcomes
Primary Outcome Measures
Safety and tolerability of metoprolol in patients treated by CAR T infusions.
Reduction of heart rate in bpm (beats per minute)
Safety and tolerability of metoprolol in patients treated by CAR T infusions.
Reduction of blood pressure in mmHg
Secondary Outcome Measures
Efficacy of metoprolol for CRS control
Reduction of Body temperature in degree centigrade
Efficacy of metoprolol for CRS precaution
Reduction of serum IL-6 in pg/dl.
Full Information
NCT ID
NCT04082910
First Posted
September 4, 2019
Last Updated
April 8, 2022
Sponsor
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04082910
Brief Title
Metoprolol Treatment for Cytokine Release Syndrome in Patients Treated With Chimeric Antigen Receptor T Cells
Official Title
Metoprolol for the Treatment of Cytokine Release Syndrome in Patients Treated With Chimeric Antigen Receptor T Cells
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2019 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this prospective study is to evaluate the feasibility and efficacy of metoprolol, a beta-1 adrenergic receptor blocker, in the treatment of cytokine release syndrome (CRS) caused by chimeric antigen receptor T (CAR T) cell infusions, its effects on the serum levels of Interleukin-6 (IL-6) and other cytokines.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor, Hematological Malignancy
Keywords
Metoprolol, cytokine release syndrome, chimeric antigen receptor T cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conditional therapy mode group
Arm Type
Experimental
Arm Description
Metoprolol (12.5-25 mg per dose, every 12 hours) was initially given from the day of CRS diagnosis confirmation post CAR T cell infusions till CRS remission in patients without bulky tumor burden. For all metoprolol-treated patients, the use of antibodies (infliximab, etanercept and tocilizumab) and/or other agents were not completely limited under the consideration of clinical requirement for sufficient control of continuously progressed CRS.
Arm Title
Prophylactic therapy mode group
Arm Type
Experimental
Arm Description
Metoprolol (12.5-25 mg per dose, every 12 hours) was given starting from the day before CAR T infusion till CRS remission in patients with bulky disease. For all metoprolol-treated patients, the use of antibodies (infliximab, etanercept and tocilizumab) and/or other agents were not completely limited under the consideration of clinical requirement for sufficient control of continuously progressed CRS.
Intervention Type
Drug
Intervention Name(s)
Metoprolol
Intervention Description
Metoprolol was given in patients who received CAR T cell therapy for CRS control or CRS precaution.
Intervention Type
Drug
Intervention Name(s)
metoprolol, infliximab, etanercept, tocilizumab and/or other agents
Intervention Description
During the term of metoprolol use, antibodies (infliximab, etanercept and tocilizumab) and/or other agents were not completely limited to be used under the consideration of clinical requirement for sufficient control of continuously progressed CRS.
Primary Outcome Measure Information:
Title
Safety and tolerability of metoprolol in patients treated by CAR T infusions.
Description
Reduction of heart rate in bpm (beats per minute)
Time Frame
2-4 weeks
Title
Safety and tolerability of metoprolol in patients treated by CAR T infusions.
Description
Reduction of blood pressure in mmHg
Time Frame
2-4 weeks
Secondary Outcome Measure Information:
Title
Efficacy of metoprolol for CRS control
Description
Reduction of Body temperature in degree centigrade
Time Frame
2-4 weeks
Title
Efficacy of metoprolol for CRS precaution
Description
Reduction of serum IL-6 in pg/dl.
Time Frame
2-4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with lymphoma, leukemia or other malignant diseases who were enrolled for CAR T cell therapy.
Exclusion Criteria:
Patients with contraindications indicated in metoprolol instruction, including:
Significant bradycardia (heart rate < 45/min)
Cardiogenic shock
Severe or acute heart failure
Poor peripheral circulation perfusion
Grade II or III atrioventricular block
Sick sinus syndrome
Severe peripheral vascular disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weidong Han, M.D.
Phone
+861066939711
Email
hanwdrsw@sina.com
Facility Information:
Facility Name
Biotherapeutic Department of Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weidong Han, M.D
Phone
+861066939711
Email
hanwdrsw@sina.com
First Name & Middle Initial & Last Name & Degree
Qingming Yang, M.D
Phone
+861066939460
Email
yangqm@medmail.com.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Metoprolol Treatment for Cytokine Release Syndrome in Patients Treated With Chimeric Antigen Receptor T Cells
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